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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Thermal Regulating
510(k) Number K024128
Device Name ALLON 2001 VERSION 5
Applicant
MTRE ADVANCED TECHNOLOGY LTD.
6052 WILMINGTON PIKE #225
CENTERVILLE,  OH  45459
Applicant Contact DOUGLAS RASH
Correspondent
MTRE ADVANCED TECHNOLOGY LTD.
6052 WILMINGTON PIKE #225
CENTERVILLE,  OH  45459
Correspondent Contact DOUGLAS RASH
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received12/16/2002
Decision Date 02/10/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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